Lawmakers Uncover Significant Gaps in COVID-19 Antibody Testing

The Subcommittee on Economic and Consumer Policy recently released a staff memo with preliminary findings that showed significant gaps in the Trump Administration’s handling of serological COVID-19 antibody testing.

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Raja Krishnamoorthi, the chairman of the Subcommittee, based the findings on a briefing with senior officials from FDA, CDC, and HHS. 

“Serology testing for coronavirus has the potential to be a critical tool going forward for our nation.  Unfortunately, senior FDA and CDC officials admitted that they have not put Americans in the best position to use this tool,” he said. 

“I was shocked to learn that we do not have the ability to know whether the available serology tests work and the FDA has no plans to make that a reality.”

One of the main challenges include the White House’s plans to reopen the economy. The lawmakers argued that the plans are flawed by their dependence on COVID-19 antibody tests, which face unanswered scientific questions. 

Additionally, FDA did not review any COVID-19 “rapid” antibody test kits before they went to market and cannot validate the accuracy of ones currently on market.

Other Subcommittee findings included: 

• Lack of enforcement by FDA has allowed manufacturers to make fraudulent claims about their efficacy
• Companies are ignoring requests from HHS to voluntarily submit their tests for validation
• FDA and CDC have not put forth standards and guidelines for serological antibody tests, departing from practices governing molecular tests
• FDA has failed to police the COVID-19 serological antibody test market, has taken no public enforcement action against any company and has not conveyed any clear policy on serological tests, but rather has issued a series of unclear clarifications

“The Subcommittee appreciates the immense challenges facing HHS, FDA, CDC, and other health agencies in the midst of the coronavirus pandemic,” Krishnamoorthi said.

 “But when it comes to serological testing, more should be done to help protect the American people from suspect companies seeking to take advantage of the crisis.  They have put the public’s health at risk by allowing inaccurate and potentially fraudulent tests to spread unchecked.”

Antibody tests can provide valuable public health information to uncover if an individual’s immune system has developed the antibodies needed to fight off infections, particularly COVID-19. 

At the end of April, Roche developed a serology test to detect antibodies in individuals who have been exposed to COVID-19. 

The Anti-SARS-CoV-2 serology test, Elecsys, is designed to identify individuals who have been infected by the virus, especially those who do not display any symptoms. The test can also screen high-risk groups including healthcare workers and food supply workers who may have developed immunity and can safely return to work. 

Once experts understand more about the immunity of COVID-19, potential drug and vaccine options will advance and help society return to normality faster. 

“Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May,” Severin Schwan, CEO of Roche Group, said in the announcement. 

The immunoassay is an in vitro test that uses human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction to SARS-CoV-2, the announcement stated.

The test may also be used in epidemiological research to uncover the spread of the disease and may also be used simultaneously with molecular tests to help the diagnosis of potential COVID-19 patients. Hospitals and other laboratories can leverage the test on Roche’s cobas e analyzers.

“Roche is deeply committed to supporting the global response to the COVID-19 pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”